I have a MBA in Healthcare Administration and Finance, a BS in Pharmacy, and a Doctorate degree in Pharmacy/Medicine. Investing in Biotechnology companies is my passion and I am also currently actively working in a teaching hospital. Also previously worked in the Pharmaceutical industry in... More

View John Li's Instablogs on:

On November 5th Immunogen (NASDAQ:IMGN)announced the halting of its Phase II trial that evaluated its compound IMGN901 for the treatment of small cell lung cancer. On the same day, Immunogen stock tumbled more than 20% as investors headed toward the exit. On that day, investors basically threw the Immunogen baby out with the bath water and over reacted.

To put IMGN901 into perspective, IMGN901 represents only 1 of 14 compounds and 1 of 19 indications Immunogen currently have in its pipeline. Furthermore, IMGN901 was evaluated for the treatment of Small-cell lung cancer (SCLC). SCLC represents only 10% of all lung cancer cases. The vast majority of lung cancer cases are Non-small cell lung cancer.

What makes IMGN901 special is that IMGN901 is a wholly Immunogen owned compound. If FDA approved IMGN901, Immunogen for the first time can keep all the revenue generated from its sale rather than relying on royalties collected from jointly developed compounds. If IMGN901 was successful, for once, Immunogen does not have to live in the shadow of its big partners.

Despite IMGN901 failure to show superior efficacy to current gold standards for SCLC treatment, Immunogen may not have given up on IMGN901 just yet. According to the company's web site, "ImmunoGen is analyzing findings with IMGN901 - including those in the Phase I/II SCLC trial - as part of assessing potential next steps for this compound." Possible future indications to be evaluated can include the treatment of CD56-positive cancers such as Merkel cell carcinoma, many cases of multiple myeloma, and other cancers of neuroendocrine origin. Based on the current Immunogen price of $13, it seems analysts and investors have already written off IMGN901 which can be the wrong assumption. Furthermore, another Immunogen's wholly owned compound IMGN853 may serve as a near term catalyst to drive up Immunogen's stock price as it completes its Phase I trial for the treatment of ovarian cancer.

In addition to partnerships, Immunogen have already jumped through the most difficult hurdle by validating the clinical usefulness of its TAP technology with the FDA approval of Kadcyla. Kadcyla is a jointly developed product between Immunogen and Genentech (now acquired by Roche). Kadcyla sales have far exceeded most analyst predictions by earning $160 million in world-wide sales. If Kadcyla is a predictor of the success of Immunogen's joint ventures, it would be reasonable to say that Immunogen's potential is incredibly undervalued by investors at $13. This price is even lower than the price Immunogen was trading at when its TAP technology was unproven. If investors will pause, evaluate Immunogen in its entirety, somewhere in the muddied water there is baby to be found.

Disclosure: I am long IMGN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

What makes Apple (NASDAQ:AAPL) an Apple is its innovation. In the past few years Apple came out with cutting edge, sexy products that just blew your mind. There was the iPhone, a touch screen hand held device that combines a mobile phone, an iPod, and internet all in one. There was also the iPad, a multi-purpose mobile device that essentially replaces the old clunky desk top for everyday use. Apple through its sexy and innovative products, packaging, and design was clearly sending out a message to the world that there is only "I". Apple is not in the company of "We".

Because Apple's products are so cutting edge and play to the imagination, Apple's earnings were stellar and easily blew pass many analysts' estimates. In a 5 year period, Apple went from $90 to a high of $700. This represents a return of 777%. A large part of Apple's success comes from its innovations driven by Steve Jobs.

Unfortunately, Steve Jobs is unique and one of a kind. Tim Cook is a very competent and capable leader when it comes to managing a company, however, Apple's stellar growth comes from innovation.

In the past few quarters, Apple's lack of innovation was clearly reflected in its earnings. Apple disappoints with -10%, -0.90%, and 2.50% EPS compared to analysts' consensus. Clearly investors' imagination of what Apple can do ran ahead of what Apple can actually do. As a result of investors lofty expectations versus what Apple can actually deliver (a smaller iPad), Apple's stock lost 17% of its value when its earnings was reported on Jan 23rd, 2013.

Although Apple's overall revenue was strong, its gross margin eroded to 38.6% compared to 44.7% in the year ago quarter. To many investors, the world of "I" created by Apple is clearly coming to an end as competitors like Samsung with more innovative and sexy products is eroding Apple's market share and mystique.

For the time being, Apple can temporary prop up its stock price by increasing dividend payments, share its cash wealth with its investors, split its shares to appeal to a bigger audience of investors, or find new partners to market its products and services. However, these are just temporary fixes that will not address the fundamental need for innovation. It is innovation that makes consumers willing to pay more that contributes to gross margins. It is innovation that drives spectacular growth.

For long term growth, I would recommend that Apple spend its huge cash reserve to clone Steve Jobs, hire some genius with similar skills to Steve Jobs, or develop a think tank with many brilliant minds that can duplicate Steve Job's vision.

Until robust innovation consistently occurs at Apple, you will see Apple's price zig-zaging with no true upward trend. How much zig or zag in Apple's price depends on which analyst you believe.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Immunogen's (NASDAQ:IMGN) Tap technology consists of a chemo agent attached to a linker. The chemo/linker compound can be attached to an antibody. The antibody acts as a "smart bomb" by carrying the chemo/linker to the cancer cell and releasing the chemo/linker payload. The cancer cell's growth is inhibited by the antibody and the cell's destruction is mediated by the linker and carried out by the chemo agent. Chemotherapy agents linked to an antibody can have less side effects and better efficacy since chemo agents are not released in the bloodstream but only on the cancer cell.

The chemo/linker technology belongs to Immunogen. The antibody portion belongs to Immunogen's partners'. Currently, Immunogen is working with eight different partners to develop products based on it's TAP technology.

T-DM1 is a product developed from Immunogen's partnership with Genentech (a subsidiary of Roche (OTCPK:RHHBF). Genentech owns the "T" antibody portion also known as Trazstuzumab (Herceptin). Immunogen owns the chemo /linker portion known as DM-1.

On August 2012, Genentech has submitted an application to the FDA for T-DM1 approval as a second-line therapy for patients with advanced metastatic breast cancer. If FDA approved, T-DM1 "an advanced version of Herceptin" can potentially replace Herceptin. Herceptin currently produces an annual sale of $5.6BB. Since Herceptin's patent expires in 2015, it would be in Roche's interest to replace Herceptin with T-DM1 as quickly as possible. For Immunogen, potential royalty payments on T-DM1 commercialization/Herceptin replacement can top $272.25MM.

The probability that the FDA will approve T-DM1 in 2012-2013 is very high. In the EMILIA trial, patients on T-DM1 were compared to two other groups of patients that were given the gold standard of drug treatment. Patients on T-DM1 have a cancer progression free survival of 9.6 months compared to 6.4 months for patients in the other groups. Furthermore, T-DM1 patients' quality of life improved. T-DM1 patients have fewer side effects and have an adverse event discontinuation rate half of that compared to patients in the other treatment groups. Given the fact that most of the advanced breast cancer patients studied have few treatment options left, it would be very difficult for the FDA not to approve T-DM1 given T-DM1's impressive survival and safety data.

The FDA's approval of T-DM1 does more than just unlocking royalty payments from Roche. The FDA approval validates Immunogen's Tap technology as being viable for commercialization. The validation of Immunogen's TAP technology paves the road for potentially unlocking $845MM in potential funding and milestone payments from Immunogen's partners. These partners include Sanofi (NYSE:SNY), Bayer (BAYRX.PK), Lilly (NYSE:LLY), Amgen (NASDAQ:AMGN), Novartis (NYSE:NVS), Biotest (OTC:BIESF) and Roche.

In addition to unlocking potential milestone payments, A validated TAP technology can also pave the way for a faster future approval and commercialization of TAP based products currently in development in Immunogen's pipeline. Currently, Immunogen has eighteen products or indications being developed in its pipeline. Immunogen 's potential royalty payments from their partners on commercialized of these products can be staggering. Analysts have yet to be able to calculate the potential royalty payments at this time.

In summary, the approval of T-DM1 by the FDA is more than just about receiving royalties from Roche. It's about validating TAP technology, unlocking Immunogen's products' potential, and transforming Immunogen into a billion dollar company with stock prices that will not be $11 anytime soon.

Disclosure: I am long IMGN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Most Commented

Posts by Themes

Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.